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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21—Food and Drugs
  4. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER H—MEDICAL DEVICES
  6. PART 820—QUALITY SYSTEM REGULATION

21 CFR Part 820 - QUALITY SYSTEM REGULATION

  • CFR
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  1. Subpart A—General Provisions (§§ 820.1 - 820.5)
  2. Subpart B—Quality System Requirements (§§ 820.20 - 820.25)
  3. Subpart C—Design Controls (§ 820.30)
  4. Subpart D—Document Controls (§ 820.40)
  5. Subpart E—Purchasing Controls (§ 820.50)
  6. Subpart F—Identification and Traceability (§§ 820.60 - 820.65)
  7. Subpart G—Production and Process Controls (§§ 820.70 - 820.75)
  8. Subpart H—Acceptance Activities (§§ 820.80 - 820.86)
  9. Subpart I—Nonconforming Product (§ 820.90)
  10. Subpart J—Corrective and Preventive Action (§ 820.100)
  11. Subpart K—Labeling and Packaging Control (§§ 820.120 - 820.130)
  12. Subpart L—Handling, Storage, Distribution, and Installation (§§ 820.140 - 820.170)
  13. Subpart M—Records (§§ 820.180 - 820.198)
  14. Subpart N—Servicing (§ 820.200)
  15. Subpart O—Statistical Techniques (§ 820.250)
Link to an amendment published at 89 FR 7523, Feb. 2, 2024.
Link to an amendment published at 89 FR 82945, Oct. 15, 2024.
Authority:
21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.
Source:
61 FR 52654, Oct. 7, 1996, unless otherwise noted.

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